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Reps. Eric Sorensen and Stephanie Bice introduce bipartisan legislation to allow FDA to deny so-called sham citizen petitions file...[ Price : $8.95]
Implantica files the final response to FDA on its PMA for RefluxStop that addresses the agencys remaining questions tied to Module...[ Price : $8.95]
FDA grants Valar Labs a breakthrough device designation for its Vesta Bladder Risk Stratify Dx test.[ Price : $8.95]
FDA approves Guardant Healths next-generation Guardant360 Liquid CDx, a blood-based comprehensive genomic profiling test designed ...[ Price : $8.95]
FDA accepts for review an ImmunityBio supplemental BLA seeking to expand the label for Anktiva (nogapendekin alfa inbakicept-pmln)...[ Price : $8.95]
FDA warns Chinas Hangzhou Yiqi Biotechnology Co. about CGMP deviations in its manufacturing of active pharmaceutical ingredients.[ Price : $8.95]
FDA publishes frequently asked questions covering eligibility, statement of interest, and selection of participants for the TEMPO ...[ Price : $8.95]
FDA warns Chinas Harbin Jixianglong Biotech about CGMP deviations and other violations in its manufacturing of active pharmaceutic...